CHAPTER VI

PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS

Provision of information to prospective donors
Article 16
Member States shall ensure that all prospective donors of blood or blood components in the Community are provided with information referred to in Article 29(b).

Information required from donors
Article 17
Member States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors in the Community provide the information referred to in Article 29(c) to the blood establishment.

Eligibility of donors
Article 18
1
Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met.
2
The results of the donor evaluation and testing procedures shall be documented and any relevant abnormal findings shall be reported to the donor.

Examination of donors
Article 19
An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components. A qualified health professional shall be responsible, in particular, for giving to and gathering from donors the information which is necessary to assess their eligibility to donate and shall, on the basis thereof, assess the eligibility of donors.

Voluntary and unpaid blood donation
Article 20
1
Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations.
2
Member States shall submit reports to the Commission on these measures two years after the entry into force of this Directive, and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at Community level.

Testing of donations
Article 21
Blood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV.
Member States shall ensure that blood and blood components imported into the Community are tested in conformity with requirements listed in Annex IV.

Storage, transport and distribution conditions
Article 22
Blood establishments shall ensure that the storage, transport and distribution conditions of blood and blood components comply with the requirements referred to in Article 29(e).

Quality and safety requirements for blood and blood components
Article 23
Blood establishments shall ensure that quality and safety requirements for blood and blood components meet the high standards in compliance with the requirements referred to in Article 29(f).